MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS SIMPLICITY; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DRN00V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information received confirmed that the lens inserted into the patient's right eye (od), then removed and replaced during the same procedure.It was indicated that the cartridge tip was not damaged and that the issue was not due to use error.The replacement lens was of model drn00v and 5.5 diopter.There was no patient injury or any complications such as capsule tear, unplanned vitrectomy, incision enlargement or sutures.It was noted that miotic agent was used.The patient outcome reported as normal.Section a2: date of birth: the exact date of birth is unknown/not provided.Only year of birth ((b)(6)) was provided.Corrected data: in review, it was noticed that date of (01/29/25) was inadvertently entered in the section "b3" which is incorrect.Therefore, the information has been corrected in this supplemental mdr report and the following field has been updated accordingly: section b3: date of event: 01/28/25.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section h3: (no).The device was not returned for evaluation (the device was discarded); therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain additional information regarding the event; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The surgery center reported a damaged intraocular lens (iol) that was fully inserted and subsequently removed due to a chunk/chip missing from it, which was not detected until after insertion.There was no incision enlargement and no sutures required.The patient has fully recovered.The doctor involved believes this issue may be due to a manufacturer defect.The lens was not saved after removal.No further information was provided.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 21437912
• Report Number: 3012236936-2025-000052
• Device Sequence Number: 11897468
• Product Code: MFK
• UDI-Device Identifier: 05050474810471
• UDI-Public: (01)05050474810471(17)270122
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown